Nurofen dla dzieci o smaku truskavkovim

1. What is Nurofen for children with strawberry flavor and what is it used for

5 ml of Nurofen for children with strawberry flavor suspension contains 100 mg of ibuprofen, which belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain, and swelling by acting at the site of their occurrence.
The medicine is intended for use in infants and children in the following cases:

• fever of various origins (also in the course of viral infections, in the course of post-vaccination reaction).
• pains of various origins of mild to moderate severity: headaches, throat and muscle pains, e.g. in the course of viral infections; muscle, joint and bone pains, as a result of injuries to the musculoskeletal system (sprains, strains); pains as a result of soft tissue injuries, post-operative pains; toothaches, pains after dental procedures, pains due to teething; headaches; ear pains occurring in inflammatory conditions of the middle ear.

2. Important information before using Nurofen for children with strawberry flavor

When not to use Nurofen for children with strawberry flavor

Nurofen for children with strawberry flavor should not be used in patients:

• with hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• who have experienced symptoms of allergy after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past (e.g. hives, rhinitis, angioedema or bronchial asthma),

Reckitt Benckiser

• with active or recurrent stomach and (or) duodenal ulcer, perforation or bleeding, also those that occurred after using NSAIDs,
• with severe liver failure, severe kidney failure or severe heart failure,
• in the third trimester of pregnancy,
• with a bleeding disorder.

Warnings and precautions

Severe skin reactions have been reported with the use of Nurofen for children with strawberry flavor. If the following occur: any skin rash, changes in mucous membranes, blisters or other symptoms of an allergic reaction, you should stop taking Nurofen for children with strawberry flavor and seek medical attention immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
When using Nurofen for children with strawberry flavor, you should consult a doctor if the child has previously had:

• an infection - see below, section entitled "Infections",
• systemic lupus erythematosus and mixed connective tissue disease symptoms of allergic reactions after taking acetylsalicylic acid,
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and (or) heart function disorder,
• kidney function disorders,
• liver function disorders,
• blood coagulation disorders,
• active or recurrent bronchial asthma or symptoms of allergic reactions in the past; after taking the medicine, bronchospasm may occur,
• taking other medicines (especially anticoagulant, diuretic, cardiac, corticosteroid medicines),
• congenital fructose intolerance (due to the possibility of maltitol, one of the excipients, being converted to fructose).

In the case of chickenpox, it is recommended to avoid using the medicine.
Infections
Nurofen for children with strawberry flavor may mask the symptoms of an infection, such as fever and pain. Therefore, Nurofen for children with strawberry flavor may delay the use of appropriate infection treatment and, as a result, lead to an increased risk of complications.
This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
In dehydrated children, there is a risk of kidney function disorder.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs.
In the event of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly (Nurofen for children with strawberry flavor may also be used by adults), should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Reckitt Benckiser
Taking medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should not use higher doses or longer treatment than recommended. If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, you should consult a doctor.
In the case of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), you should discuss the treatment with a doctor or pharmacist.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, or if you suspect that you are pregnant, or if you plan to become pregnant, you should consult a doctor or pharmacist before using this medicine.
During the first 6 months of pregnancy, it is not recommended to use the medicine. During the last three months of pregnancy, you should not take the medicine, as it may increase the risk of complications in the mother and child during the perinatal period.
Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse reactions in breastfed infants, so there is no need to discontinue breastfeeding.

Nurofen for children with strawberry flavor contains liquid maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Nurofen for children with strawberry flavor and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, even those that are available without a prescription.
You should avoid taking Nurofen for children if you are using other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), acetylsalicylic acid, or other painkillers.
Nurofen for children should be used with caution with the following medicines:

• antihypertensive medicines (e.g. diuretics),
• anticoagulant medicines,
• zydovudine,
• lithium and methotrexate,
• corticosteroids,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs),
• cardiac glycosides,
• cyclosporine,
• mifepristone,
• tacrolimus, quinolone antibiotics

3. How to use Nurofen for children with strawberry flavor

Reckitt Benckiser
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
You should use the smallest effective dose for the shortest period necessary to relieve the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult a doctor immediately (see section 2).
A measuring spoon with a capacity of 2.5 ml/5 ml is attached to the packaging to facilitate dosing.
You should shake the bottle before use.
or
A dosing device in the form of a syringe with a scale facilitating dosing is attached to the packaging.

Instructions for use

• 1. You should unscrew the bottle cap (press down and turn in the opposite direction to the clockwise direction).
• 2. The dosing device should be firmly pressed into the opening in the neck of the bottle.
• 3. The bottle should be shaken vigorously.
• 4. To fill the dosing device, the bottle should be turned upside down and then carefully move the plunger of the dosing device down to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the dosing device should be carefully screwed out of the bottle.
• 6. The tip of the dosing device should be placed in the child's mouth, and then, slowly pressing the plunger, the contents of the dosing device should be carefully emptied.
• 7. After use, the bottle should be closed by screwing the cap, and the dosing device should be washed and dried.

Method of administration

For oral use.
The medicine is intended for short-term use only.
The recommended daily dose of the medicine is 20-30 mg per kilogram of body weight, divided into equal doses administered at intervals of 6 to 8 hours. You should not use a higher dose of the medicine than recommended.
Reckitt Benckiser

Children under 6 months old can be given the medicine only after consulting a doctor.
You should not use this medicine in children with a body weight of less than 5 kg.
In the case of children aged 3-5 months, you should consult a doctor if the symptoms worsen or do not improve after 24 hours.
In the case of children over 6 months old, you should consult a doctor if the administration of the medicine is necessary for more than 3 days or if the symptoms worsen.

Special patient groups

Post-vaccination fever (children aged 3-6 months): The recommended daily dose of the medicine is 1 x 50 mg; if necessary, a second dose of 1 x 50 mg can be taken after 6 hours. You should not exceed the dose of 2 x 50 mg in 24 hours. If the fever does not decrease, you should consult a doctor.

Using a higher than recommended dose of Nurofen for children with strawberry flavor

Cases of overdose are rare. However, if the patient has used a higher dose of Nurofen for children with strawberry flavor than recommended or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on the possible health risk and advice on what actions to take in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headaches, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing problems may occur.
The following may also occur: abdominal pain or, less frequently, diarrhea, gastrointestinal bleeding, very rarely excitement or coma, metabolic acidosis, increased prothrombin time/INR, acute kidney failure or liver damage, and in patients with asthma - worsening of asthma symptoms.
There is no specific antidote. Treatment is symptomatic and supportive, consisting of cleansing the body. The doctor will monitor heart function and control vital signs, if they are stable. The doctor will consider administering activated charcoal orally within 1 hour of overdose.
In the case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In the case of patients with asthma, the doctor will administer bronchodilators.

Missing a dose of Nurofen for children with strawberry flavor

You should not use a double dose to make up for a missed dose.
Reckitt Benckiser

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed. When using ibuprofen for other indications and long-term, other side effects may occur.
If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult a pharmacist or doctor.
Side effects are ranked according to frequency of occurrence using the following terms:
Very common (occurring more frequently than 1 in 10 patients)
Common (occurring more frequently than 1 in 100 patients)
Uncommon (occurring more frequently than 1 in 1,000 patients)
Rare (occurring more frequently than 1 in 10,000 patients)
Very rare (occurring less frequently than 1 in 10,000 patients)

Uncommon:

hypersensitivity with hives and itching
headaches
stomach pain, nausea, and indigestion
skin rash

Rare:

dizziness, insomnia, agitation, irritability, or feeling tired. In individual cases, depression, psychotic reactions, and tinnitus have been reported.
diarrhea, bloating, constipation, vomiting, and gastritis
edema

Very rare:

blood disorders
severe hypersensitivity reactions, including face, tongue, and throat edema, dyspnea, tachycardia, and hypotension (anaphylaxis, angioedema, or shock)
aseptic meningitis
heart failure and edema
hypertension
respiratory tract reactivity, including asthma, bronchospasm, or dyspnea
peptic ulcer, perforation, or gastrointestinal bleeding, black stools, and bloody vomiting, oral ulceration, exacerbation of ulcerative colitis and Crohn's disease
liver disorders
bullous reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis
severe skin and soft tissue infections in the course of chickenpox. Worsening of infectious conditions (e.g. necrotizing fasciitis) has been reported during the use of some painkillers (NSAIDs).
acute kidney failure
decreased hemoglobin levels

Frequency not known:

severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell)
Reckitt Benckiser
a red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Nurofen for children with strawberry flavor and seek medical attention immediately. See also section 2.
the skin becomes sensitive to light

If any of the side effects worsen or if you experience any side effects not listed in this leaflet

you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Nurofen for children with strawberry flavor

There are no special recommendations for storage conditions.
The opened packaging should be used within 6 months.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Nurofen for children with strawberry flavor contain

5 ml of Nurofen for children with strawberry flavor contains:
Active substance: ibuprofen 100 mg
Other ingredients are: polysorbate 80, glycerol, liquid maltitol, sodium saccharin, citric acid monohydrate, sodium citrate, xanthan gum, sodium chloride, strawberry flavor 500244E, bromhexine hydrochloride, purified water.

What Nurofen for children with strawberry flavor looks like and what the packaging contains

A bottle containing 100 ml or 150 ml of oral suspension 100 mg/5 ml.
A measuring spoon with a capacity of 2.5 ml/5 ml is attached to the packaging to facilitate dosing.

Marketing authorization holder and importer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
Reckitt Benckiser
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Hotline number: 801 88 88 07
Date of last update of the leaflet: 03/2021